Technical Writer

Job Responsibilities

• Employ effective technical writing techniques to create clear, concise, and comprehensive documentation.
• Develop and update technical documents such as facility and equipment Standard Operating Procedures (SOPs), batch records, specifications, and training materials.
• Initiate and manage change controls to introduce new procedures and revise existing documentation and SOPs for new product launches.
• Engage in process and equipment testing to gain a thorough understanding of the systems being documented.
• Complete deviations, Corrective and Preventive Actions (CAPAs), change controls, document revisions, and training tasks to meet quality system standards and deadlines.
• Collaborate with operations, R&D, and quality teams to ensure all documentation requirements for projects are met.
• Ensure adherence to US and international regulatory standards and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).

Qualifications

• Bachelor's degree or equivalent work experience.
• Minimum of 3 years of relevant experience.
• Strong communication skills in English, including grammar and composition.
• In-depth knowledge of GMP/cGMP regulations.
• Excellent written and verbal communication skills with the ability to work with cross-functional teams.
• Strong time management skills and attention to detail.
• Proven ability to handle multiple projects in a fast-paced, professional environment.
• Ability to work independently and collaboratively.
• Proficient in reading, understanding, and following work instructions safely, accurately, and promptly.
• Proficiency in Microsoft Word, PowerPoint, and Excel.

Contact your Recruiter:

For more information about the role and to express your interest, you can reach out to our recruiter, Zhanri, directly:

• Email: zdesphy@harbasolutions.com
• Phone: 617.284.4255

About Harba Solutions:

Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.